BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1900551 · Received October 29, 2010

    Report

    Report Number
    1219856-2010-00766
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TALKING WITH THE PERFUSIONIST ABOUT THE FIELD SAFETY ALERT, HE STATED THAT "ONE OF THE SURGEONS HAD AN INCIDENT ABOUT A MONTH AGO IN WHICH THEY WENT THROUGH THREE IAB-05840-LWS'S TO GET ONE INSERTED." THE INSERTION SITE WAS THE FEMORAL ARTERY. FURTHER DISCUSSION ON (B)(4) 2010, WITH CLINICAL SPECIALIST WHO WAS AT THE ACCOUNT, INDICATED THIS PT IS FINE AND HAD NO COMPLICATIONS. REFERENCE MDR # 1219856-2010-00764 FOR THE FIRST EVENT AND MDR # 1219856-2010-00765 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK